Cleared Traditional

K251400 - T2 Alpha Humerus Nailing System

Also marketed or referenced as:
IMN Screws System T2 Nailing System

K251400 is the FDA 510(k) clearance for T2 Alpha Humerus Nailing System by Stryker GmbH. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K251400 · Stryker GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
106d
Days
Class 2
Risk

K251400 is an FDA 510(k) clearance for the T2 Alpha Humerus Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker GmbH (Selzach, Solothurn, Ch, CH). The FDA issued a Cleared decision on August 20, 2025 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker GmbH devices

Submission Details

510(k) Number K251400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2025
Decision Date August 20, 2025
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 318
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K251400.
ARIX Femur Nail System
K252826 · Jeil Medical Corporation · Dec 2025
Estremo Fibular Nail
K250197 · Citieffe S.R.L. · Oct 2025
DynaNail TTC Fusion System
K250628 · MedShape, Inc. · Sep 2025
T2 Alpha Femur Retrograde Nailing System
K250163 · Stryker GmbH · Aug 2025
Succession™ AFN System
K250622 · Ortho Solutions UK , Ltd. · Aug 2025
Phantom® Hindfoot TTC/TC Nail System
K251850 · Paragon 28, Inc. · Jul 2025